This application relates to a connector for connecting a lead to an energy source such as a cardiac stimulator.
Connector assemblies are used to couple a conductor with a device. For instance, a connector is used to couple a cardiac stimulator system such as a pacemaker, an anti-tachycardia device, a cardioverter or a defibrillator with a lead having an electrode for making contact with a portion of the heart.
When leads with multiple conductors are involved, the conductors are individually, mechanically and electrically coupled with the pulse generator at a proximal end of the multiple conductors. The multiple conductors at the proximal end are electrically insulated from each other to prevent shorts and limit electrical leakage between conductors. Medical adhesive is used to bond and insulate the multiple conductors at the proximal end of the lead. However, the process of using medical adhesive is timely and costly. In addition, the medical adhesive bonds inconsistently, sometimes resulting in mechanical and electrical separation between the components, and resulting in dimensional inconsistency.
The proximal end of the lead includes a terminal connection which provides the electrical and mechanical connection between the pacemaker and the proximal end of the lead. When inserted into the pacemaker, the components of the terminal connection undergoes axial stress as the implanter forces the proximal end of the lead into the pacemaker. After inserted, the implanter may pull on the lead to ensure the terminal end is sufficiently seated in the pacemaker, placing additional axial stress on the terminal connection.
In addition, connector assemblies are subjected to a variety of tests including axial loading to test the strength of the coupling of the components. Existing connector assemblies often include numerous components and require numerous steps in the assembly process to provide the desired connection between the components. Connector designs include components that are welded together, bonded with adhesive or a combination of both. Welded components require subassembly prior to assembly with other components and may require additional components suitable for making weld connections. Bonding components with adhesive also requires subassembly. Additionally, bonding components with adhesive requires time to cure and is a messy process. Connector designs including components that are welded together or bonded with adhesive or a combination of both add additional elements and steps to the manufacturing and assembly process. These additional elements increase the complexity of the component and can represent a bottle-neck in the manufacturing and assembly process of the connector assembly.
A connector assembly includes a pin extending from a pin distal end to a pin proximal end. The pin further includes an intermediate portion between the distal end and the proximal end. In addition, the connector assembly includes at least one ring extending from a ring distal end to a ring proximal end and having a ring intermediate portion therebetween. A molded insulative polymer is between the pin and the ring, the polymer mechanically couples the pin and the ring, and the insulative polymer insulates the pin from the ring.
Several options for the connector assembly are as follows. For instance, in one option, the pin has a first outer diameter and the ring has a second outer diameter, and the first diameter is substantially the same as the second diameter. In another option, the connector assembly further includes a second ring, and the insulative polymer is between the pin, the first ring and the second ring, and the second ring is mechanically coupled to the pin by the polymer. In another example, the ring further includes at least one passage, and the molded polymer is molded within the at least one passage. The pin includes, in another option, at least one chamfer, and the molded insulative polymer is molded within the chamfer.
Other options are follows. For instance, the pin optionally has at least one chamfer formed thereon. In another option, the ring includes a full boss and a full chamfer, and/or the ring includes an extension thereon, the extension having a partial boss and a partial chamfer thereon. In yet another option, an interior surface of the ring includes grooves formed thereon, or the grooves are oblique to a longitudinal axis of the ring. The pin further optionally includes a boss formed thereon, and/or the pin boss further includes grooves formed thereon, and/or the pin further includes grooves formed on a distal portion of the pin.
In another embodiment, an assembly comprises a connector assembly. The connector assembly includes a pin extending from a pin distal end to a pin proximal end, and having a pin intermediate portion therebetween. The connector assembly further includes at least one ring extending from a ring distal end to a ring proximal end and having a ring intermediate portion therebetween, and a molded insulative polymer between the pin and the ring, the polymer mechanically couples the pin and the ring, and the insulative polymer insulates the pin from the ring. The assembly further includes a lead having a lead body, the lead coupled with the connector assembly.
Several options for the assembly are as follows. For instance, the connector assembly has a first outer diameter, the lead having a second outer diameter, and the first outer diameter and the second outer diameter are substantially the same. In another option, the connector assembly further includes a groove on an outer diameter of the connector assembly, the groove configured to receive a portion of a pulse generator, and/or the connector assembly further includes a second groove on the outer diameter. In another option, a second ring, and a third ring, and the insulative polymer is between the pin, the first ring, the second ring, and the third ring, the second ring and the third ring mechanically coupled to the pin by the polymer. In yet another option, the pin further includes a pin boss formed thereon, and the pin boss further includes grooves formed thereon.
In one embodiment, a method comprises forming a pin, forming at least one ring, molding a sleeve between the pin and the ring, including mechanically coupling the pin with the ring. Several options for the method are as follows. For instance, the method further comprises coupling a lead with the pin, the at least one ring, and the sleeve to form an assembly having an isodiametric outer diameter. In another option, the method further includes forming a second ring, and molding the sleeve between the ring, the pin, and the second ring. In yet another option, the method further includes swaging a conductor within a passage of the at least one ring, and/or welding a conductor within a passage of the at least one ring. A further option for the method includes forming an extension on the ring, and/or forming a partial boss and a partial chamfer on the extension.
The construction of the connector does not require weld joints or adhesive bonds between components. The result is a connector with fewer components, fewer steps in the assembly process, reduced size and smaller diameter, improved insulative properties and improved mechanical strength. The connector is useful for unipolar, multipolar, uniradial, and co-radial construction.
These and other embodiments, aspects, advantages, and features of the present invention will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art by reference to the following description of the invention and referenced drawings or by practice of the invention. The aspects, advantages, and features of the invention are realized and attained by means of the instrumentalities, procedures, and combinations particularly pointed out in the appended claims and their equivalents.